Sonography-Guided Volumetric Rejuvenation on Dorsal Hands | NCT05819450

Studies
Sonography-Guided Volumetric Rejuvenation on Dorsal Hands

NCT05819450

Sponsor

Chang Gung Memorial Hospital

Status

Unknown status

Last Update Posted

Aug 30, 2023Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Ultrasound
Injection Site

Interventions

Volumetric rejuvenation

Countries

Spain
Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2023Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Apr 6, 2023

First Submission Date that Met QC Criteria

Apr 6, 2023

First Posted Date

Apr 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2023

Last Update Posted Date

Aug 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this randomized controlled study is to guide volumetric rejuvenation on dorsal hands with the maximal aesthetic appearance. The main questions it aims to answer are:

Which fatty layer(s) is/are the most suitable for filler injection?
Is it feasible to make precise filler injections with sonography guidance? Participants will receive sonography-guided injection on the one hand and another with blinded injection.

Detailed Description

In our previous study, volumetric fat loss was noted in the 3 fatty laminae of dorsal hands during aging; the dorsal intermediate lamina (DIL) showed the greatest progressive fat loss after the age of 30. Volumetric rejuvenation of the 3 laminae may result in the most aesthetic appearance, especially in women. It is necessary to develop precise rejuvenation therapies according to the aging process of the dorsum of the hands that will yield the most aesthetic appearance.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sonography-guided hand	Experimental	One hand of the participant will be treated with sonography-guided filler injection in random	Procedure: Volumetric rejuvenation
Blinded injected hand	No Intervention	One hand of the participant will be treated with filler injection by physician's experience without sonography-guidance in random

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Volumetric rejuvenation	Procedure	Volumetric Rejuvenation with FDA-approved fillers on the skin of the dorsal hands	Sonography-guided hand

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aesthetic improvement	5-point global aesthetic improvement scales scoring (Min:1; Max:5)	Day 0, 30, 180 follow up

Secondary Outcomes

Measure	Description	Time Frame
Thickness of the fatty laer	Thickness of the dorsal superficial lamina (DSL) and dorsal intermediate lamina (DIL)	Day 0, 30, 180 follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of aging changes on the dorsal hands
Aged ≥18 years

Exclusion Criteria:

History of severe hand dermatitis
History of rheumatic arthritis
History of major hand trauma
History of limb edema
History of recent significant weight changes
History of previous filler injection to the dorsal hands
History of intravenous catheter insertion and hemodialysis via the forearms or hands

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yi-Teng Hung, MD	Contact	+886972392650		herovincent25@hotmail.com.tw

Overall Officials

Name	Affiliation	Role
Yi-Teng Hung, MD	Chang Gung Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ocean Clinic Marbella	Recruiting	Marbella			Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided